RU2665019C1 - Method for detecting rhythm disturbances and conduction in patients with epilepsy by using an implanted subcutaneous ecg loop register - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine, neurology and cardiovascular therapy. Subcutaneous loop ECG recorder is implanted in patients with epilepsy belonging to sudden death high-risk groups, as well as patients suffering from diseases hard to cure. Wherein the information is read with the help of a corresponding software device. Then, in the event of an epileptic attack, the patient or his/her relative/guardian activates the subcutaneous loop ECG recorder with the help of an external activator followed by the recording of the obtained information. Wherein the subcutaneous loop ECG recorder is activated with the development of a simple focal attack without impairment of consciousness, or with the development of a focal auto-motor or generalized attack with impairment of consciousness without precursor symptom once immediately after the attack. Or, with the development of a focal auto-motor or generalized attack with impairment of consciousness with precursor symptom two times: the first time – during precursor symptom, the second time – immediately after rapid relief of symptoms. Or, with the development of epileptic status/series of attacks twice: the first time – during the status/series of attacks, the second time – at the time of restoration of consciousness or in the absence of signs of an ongoing attack.EFFECT: method allows increasing the frequency of heart rhythm disturbances and cardiac conduction in patients with epilepsy and implanted subcutaneous loop ECG recorder.1 cl, 2 dwg, 1 ex

Description

Technical field

The invention relates to medicine, and more specifically to the formation of an algorithm for a patient to activate a subcutaneous loop ECG recorder using an external device in order to optimize the detection of arrhythmias and cardiac conduction in patients with epilepsy.

State of the art

65 million people worldwide suffer from epilepsy, and despite treatment, more than 1 million patients still have epileptic seizures. Patients with epilepsy have an increased risk of death compared with the general population, with about half of the patients dying suddenly [http://www.epilepsy.com/learn/impact/mortality/sudep].

In recent years, data have been obtained indicating that one of the main causes of sudden death in patients with epilepsy is a disturbance in the rhythm and conduction of the heart. Along with supraventricular, fatal ventricular arrhythmias, significant episodes of impaired sinoatrial and atrioventricular conduction are recorded in this group of patients. Conducted electroencephalographic studies in combination with long-term recording of an electrocardiogram (ECG) reveal various types of cardiac arrhythmias and cardiac conduction in 40-44% of patients with epilepsy. [Oppenheimer S.M., Cechetto D.F., Hachinski V.C., 1990; Lhatoo S.D., Langan Y., Sander J.W., 1999; Opherk C., Coromilas J., Hirsch L.J., 2002]. Cardiac arrhythmias are recorded both in the ictal and postictal periods, and in some cases are asymptomatic. In this connection, long-term ECG registration is advisable for their identification, which is possible with implantation of a subcutaneous ECG monitor. This device carries out continuous ECG recording by both automatic detection of arrhythmic events and autoactivation by the patient, analyzes and stores information in the “memory”.

The subcutaneous ECG monitoring system consists of three main components - a programming device, a direct loop ECG recorder, and an external activator (“assistant” / assistant console) of the patient. The duration of continuous ECG monitoring can be from 2 to 3 years, depending on the number of autoactivations. The total duration of ECG fragments stored in the device’s memory is 49.5 minutes, of which 22.5 minutes are activated by the patient, and up to 27 minutes of automatically detected episodes. In addition, there is the possibility of dubbing the most numerous and "old" of the events recorded in automatic mode. In some cases, the device’s auto-activation coincides with the clinical manifestations of cardiac arrhythmias and cardiac conduction, but nevertheless, it cannot replace the correct use of the patient’s activator.

Thus, in connection with the possible development of life-threatening cardiac arrhythmias and conduction disorders in patients with epilepsy, the difficulty of identifying them at the time of the development of an epileptic seizure, implantation of a subcutaneous ECG recorder using a newly formulated algorithm for activating patient recording can be recommended in this group of patients for long-term registration ECG in order to stratify the risk of sudden cardiac death and choose a method for its prevention.

Only three studies are known from the prior art that were performed to detect cardiac arrhythmias by prolonged recording of an ECG, however, the number of examined patients was small and did not exceed 20 people.

There is a method of long-term registration of heart rhythm and repolarization disorders in patients with pharmacologically resistant focal and generalized forms of epilepsy (Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy; Maromi Nei, Michael R. Sperling, Scott Mintzer, and Reginald T. Ho ; Epilepsia, 53 (8), 2012). For its implementation, in a prospective examination, 19 patients with pharmacologically resistant focal and generalized forms of epilepsy underwent implantation of a subcutaneous loop ECG recorder with programming of a device for automatic detection of arrhythmias. In addition, recommendations were given on the use of an external recording activator in the development of epileptic seizures. During the observation period of 12-19 months, the total number of seizures was 1477. Rhythm and conduction disturbances were recorded in 42% of patients during the development of generalized seizures. Unfortunately, the type of attack and the activation time of the device were not taken into account, which further complicated the interpretation of the data obtained in connection with the registration of artifacts during seizures.

There is another method for diagnosing cardiac arrhythmias with the detection of generalized tonic-clonic seizures detected by implantable loop recorder devices: Diagnosing more than cardiac arrhythmias; Reginald T. Ho, MD, Tammi Wicks, Dale Wyeth, Maromi Nei; Heart Rhythm, Vol. 3, No. 7, July 2006), in which, while recording EEG and ECG using a subcutaneous cardiomonitor, it was possible to fix the tonic and clinical phases of epileptic seizures in 14 patients .. And although the loop recorder is not able to register brain electrical Act Evenness, artifacts of contracting skeletal muscles, which have a characteristic morphology (coinciding with typical changes on the EEG), were detected by the device. Thus, long-term ECG recording proved to be appropriate not only in groups of patients with a high risk of sudden cardiac death, but also was a tool for verifying the diagnosis of epilepsy. However, these episodes were not automatically recognized and required activation of the recording using the remote assistant in all cases.

Closest to the claimed invention is a method for recording heart rhythm and disorders in patients with focal pharmacoresistant forms of epilepsy (Cardiac arrhythmias in focal epilepsy: a prospective long-term study; J Rugg-Gunn, Robert J Simister, Mark Squirrell, Diana R Holdright, John S Duncan; The Lancet, Volume 364, Issue 9452, 18-31 December 2004, Pages 2212-2219) in which 18 patients with focal pharmacoresistant forms of epilepsy were implanted with subcutaneous loop ECG recorders for 18 months. In the process of observation, 3377 epilepsy episodes were recorded, the ECG was recorded during 377 seizures. In addition, the ability of the subcutaneous loop ECG recorder to record life-threatening rhythm and conduction disturbances in patients with pharmacologically resistant forms of epilepsy was first demonstrated. Despite the fact that an attempt was made to a systematic approach to the use of a recording activator by a patient, there was a device auto-activation, in connection with which his memory was filled with events that were not related to significant electrocardiographic changes.

Thus, the lack of a unified approach to the use of a patient’s activator significantly reduced the information content of fragments stored in the device’s memory.

The task of the invention is to identify violations of the rhythm and conduction of the heart in patients with epilepsy, stratification of the risk of sudden death, and, if necessary, the appointment of antiarrhythmic therapy, or surgical treatment of arrhythmias.

Disclosure of invention

The technical result of the claimed method is to increase the efficiency of detecting cardiac arrhythmias and conduction disorders in patients with epilepsy and an implanted subcutaneous loop ECG recorder, which is achieved due to the fact that patients with epilepsy, belonging to the high risk groups of sudden death, as well as patients suffering from difficult to ship forms of the disease carry out subcutaneous implantation of an ECG recorder, followed by setting its operation parameters, while reading information and tuning exist using a software device (for example, the company Metronik) that also allows you to read information from a cardiomonitor, then when an epileptic seizure occurs, the patient or his relative / guardian activates the subcutaneous loop ECG recorder using an external activator, followed by recording the information received, which, unlike the prototype involves the activation of a subcutaneous ECG recorder in the corresponding period of an epileptic seizure, depending on its type and level of consciousness b olny, or once or twice taking into account the following algorithm:

In the case of the development of a simple focal epileptic seizure without impaired consciousness, the patient’s activator is used once immediately after the seizure.

In the case of the development of a focal automotor or generalized epileptic seizure proceeding with impaired consciousness

a) with aura - the patient’s activator is used twice - the first time during the aura, the second - immediately after the attack;

b) without an aura - the activator is used once immediately after the completion of the attack;

In case of the development of an epileptic status or a series of epileptic seizures, the patient’s activator is used twice: the first - during the status / series of seizures, the second - at the time of recovery of consciousness, or / or the absence of signs of an ongoing attack;

In the case of post-entry confusion, the recording is activated by the patient's relative / guardian once immediately after the attack.

The claimed invention is illustrated:

- figure 1, which shows the algorithm for using an external activator in patients with epilepsy and an implanted subcutaneous loop ECG recorder;

- figure 2, which shows a record from a subcutaneous recording device in a patient with a generalized epileptic seizure: transformation of the tonic phase of seizures into clonic (fragments 1 and 2), frequent supraventricular extrasystole (fragment 3), an episode of atrial fibrillation (fragment 4).

The implementation of the invention

The use of a subcutaneous loop ECG recorder is recommended for patients with high risk of sudden death epilepsy, as well as for patients suffering from difficult to ship forms of the disease. After implantation of a subcutaneous loop ECG recorder, the parameters of its operation are adjusted. Reading information (as well as setting parameters) is carried out using a programming device. The saved ECG fragments are presented in the form of electrograms, accompanied by time intervals and detection markers.

There are two ways to activate recording of a subcutaneous loop ECG recorder:

1) automatically according to 6 programmable triggers - asystole (pauses), bradycardia, ventricular tachycardia, fast ventricular tachycardia, atrial tachyarrhythmias / atrial fibrillation. The duration of the episodes stored in the memory is 30 seconds before and 30 seconds after the moment of activation, for atrial tachyarrhythmias - 2 minutes prior to auto-activation.

2) Upon activation of the recording by the patient or his relatives / guardians, the following can be stored in the device memory: a) 3 episodes of 6.5 minutes before and 1 minute after using the activator; b) 2 episodes of 10 minutes before and 2 minutes after using the activator; c) one episode lasting 15 minutes before and 7.5 minutes after using the activator.

Thus, in the event of an epileptic seizure, the patient or his relative / guardian performs activation of the subcutaneous loop ECG recorder using an external activator. It should be noted that during the entire period of observation of the patient an individual selection of settings for recording activation is carried out depending on the frequency of occurrence and the type of seizure. Using an external activator involves activating a record once or twice and is presented in the form of the following algorithm:

In the case of the development of a simple focal epileptic seizure without impaired consciousness, the patient’s activator is used once immediately after the seizure.

In the case of the development of a focal automotor or generalized epileptic seizure proceeding with impaired consciousness

a) with aura - the patient’s activator is used twice - the first time during the aura, the second - immediately after the attack;

b) without an aura - the activator is used once immediately after the completion of the attack;

In case of the development of an epileptic status or a series of epileptic seizures, the patient’s activator is used twice: the first - during the status / series of seizures, the second - at the time of recovery of consciousness, or / or the absence of signs of an ongoing attack;

In the case of post-entry confusion, the recording is activated after the attack is completed by the patient's relative / guardian

Thus, depending on the type of epileptic seizure, the presence or absence of an aura, as well as post-entry confusion for effective diagnosis of rhythm and conduction disorders in patients with epilepsy, an external activator of ECG recording is used:

1. Once: a) with the development of a simple focal attack without impaired consciousness (immediately after the attack); b) with the development of a focal automotor or generalized attack with impaired consciousness without an aura (immediately after the attack);

2. Twice: a) with the development of a focal automotor or generalized attack with impaired consciousness with an aura (once during the aura, the second immediately after stopping the attack); b) with the development of an epileptic status / series of seizures (once - during the status / series of seizures, the second - at the time of recovery of consciousness, or / or the absence of signs of an ongoing attack).

Due to the possibility of combining several types of epileptic seizures in one patient, the use of the patient’s activator should be supplemented by keeping a diary with an indication of the type of seizure, the time of its occurrence for further comparison of the patient’s notes with information stored in the device’s memory.

The frequency of visits to the clinic for “reading” indications from the recording device depends on the frequency of occurrence of epileptic seizures and the number of recording activations by the patient (depending on the program chosen by the doctor). If it is impossible to activate the recording by the patient or his relative / guardian, the dates for visiting the medical institution are determined individually.

Examples of the proposed method

Patient A., 44 years old, with a diagnosis of symptomatic focal epilepsy with complex partial, simple partial and secondary-generalized seizures, in which, despite taking antiepileptic therapy, seizures with a frequency of up to two times a month persist, a subcutaneous loop ECG recorder was implanted. The device was programmed for automatic detection of arrhythmias, in addition, the patient was trained to use the assistant console independently, depending on the type of epileptic seizures that occur.

During a planned patient visit to the clinic, information was read from a cardiomonitor. The recording was activated by the patient three times immediately after the end of the attack - in all cases there was a development of a generalized attack, accompanied by loss of consciousness, without a previous aura.

On the ECG, artifacts were recorded that were characteristic of skeletal muscle contractions at the moment of development of the tonic and then clonic phases of seizures, subsequently followed by frequent supraventricular extrasystole and finally the development of a stable episode of atrial fibrillation with CSF up to 150 beats per minute (Fig. 2).

Claims (4)

A method for detecting cardiac arrhythmias and conduction disorders in patients with epilepsy using an implanted subcutaneous loop ECG recorder, characterized in that patients with epilepsy, who are at high risk of sudden death, as well as patients suffering from hard-to-cure forms of the disease, undergo subcutaneous implantation of a subcutaneous loop recorder ECG, while reading information is carried out using the appropriate software device, then when an epileptic about an attack, the patient or his relative / guardian activates the subcutaneous loop ECG recorder using an external activator, followed by recording the information received, characterized in that the activation of the subcutaneous loop ECG recorder is performed: with the development of a simple focal attack without impaired consciousness, or with the development of a focal automotor or generalized attack with impaired consciousness without an aura once immediately after the attack; with the development of a focal automotor or generalized attack with impaired consciousness with an aura twice: the first time during the aura, the second immediately after stopping the attack; with the development of an epileptic status / series of seizures twice: the first time during the status / series of seizures, the second at the time of recovery of consciousness or in the absence of signs of an ongoing seizure.

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